IT VALIDATION COURSE

The 2 Day Course is based on GAMP® 5, 21 CFR Part11 and EU GMP Annex 11.

The Course Participants will be equipped with skills and knowledge to perform a full IT Validation of a Computerized Systems.

For Validation Strategy the V model is used.

Based on a predetermined Case Study, the course participants will attend 6 workshops.

Learning objectives

  • Understanding GAMP® 5 & 21 CFR Part11 /Annex 11
    • Categorize SW & HW according to GAMP® 5
  • Performing Science Based Risk Assessment
  • Performing Supplier Assessment
  • Producing Validation Master Plan & Validation Plan
    • Validation approach according to GAMP® 5 categorization
  • Producing Specifications
    • User Specification Requirement
    • Functional Specification
    • Design Specification
  • Reviewing the Design & Software
  • Ensure Traceability
  • Producing System Description & Dataflow
  • Producing Testing documentation
  • Securing Maintenance throughout the Life Cycle
  • Understanding Incident, Change & Configuration Management
  • Producing Continuity Plan & Disaster Recovery Plan
  • Planning System Retirement

Course format

The Course is a combination of lecture-style leaning and active Workshops with participants working in small groups on assigned tasks.

Program

  • Day 1
    • Learning about GAMP®5 and 21 CFR Part11
      • Categorize SW & HW according to GAMP
    • Science Based Risk Assessment
    • Supplier Assessment
    • Validation Master Plan / Validation Plan
      • Validation approach according to GAMP categorization
    • Specifications
    • Configuration and Design
    • Design Review
      • Workshop 1 & 2 & 3 & 4
  • Day 2
    • Testing Computerized System
    • Handover
    • Maintenance
    • Incident, Change and Configuration Management
    • Continuity Plan / Disaster Recovery
    • Retirement of a Computerized System
    • Workshop 5 & 6

Course Duration and location

2 Days at Pharmakon.

Next planed date is: 11. June – 12. June 2020 and 10. – 11. December 2020.

Course Material

Participants will receive the presentation, a complete guide, and other useful information.

Call: +45 50556005 or email: jg@qv-compliance.dk if you have any questions or sign up via:

Link to Pharmakon

Customized Courses

We also offer customized courses, to suit your every need – we have hosted specially customized courses, on many different subjects – durations varying from half a day brush-up, to a full week seminar, on project dedicated education.

Call: +45 50556005 or email: jg@qv-compliance.dk if you have any questions.